FDA-AACR-IASLC Workshop to Address Tobacco Use Assessment in Clinical Trials

By Carmine S. Leggett, PhD

Clinical trials in oncology have changed the face of cancer treatment, allowing cancer researchers and clinicians from multiple disciplines to make great advances in decreasing cancer mortality. Many factors affect outcomes in clinical trials, including socioeconomic and insurance status, efficacy of study design, and lifestyle behaviors such as tobacco use.

While the causal association between tobacco use and cancer is well understood, less has been done to evaluate and implement systematic assessment of tobacco use in clinical trials. Therefore, there are limited data captured on tobacco and e-cigarette use patterns in cancer patients and survivors. The 2020 Surgeon General’s report emphasizes the numerous health benefits of smoking cessation, including reducing the risk of many cancers, suggesting the need for structured tobacco cessation efforts, which are not well incorporated into standard care for patients with cancer. 

To provide an open forum to discuss these issues and improve public understanding of the significance of continued tobacco use on health outcomes in clinical trials, the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE), the American Association of Cancer Research (AACR), and the International Association for the Study of Lung Cancer (IASLC) are cosponsoring the Workshop to Address the Criticality of Tobacco Use Assessment in Oncology Therapeutic Trials on February 28, 2020, at the FDA White Oak Campus in Silver Spring, Maryland.

Michael E. Menefee, MD

“This workshop will bring academic, government, and industry scientists together with patient advocates to discuss how tobacco use impacts oncology therapeutic clinical trials,” said FDA Oncology Center of Excellence cochair Michael E. Menefee, MD. “We hope that the discussion will help pave the way to improve assessment of tobacco use in drug development.”

Matthew Steliga, MD

IASLC cochair Matthew Steliga, MD, from the Winthrop P. Rockefeller Cancer Institute, said, “Through this workshop, we hope to identify best practices and barriers to assessing tobacco use in oncology therapeutic clinical trials. Tobacco use impacts outcomes in any cancer care, so it needs to be assessed. However, assessment approaches need to be consistent and cannot be burdensome. We have to strike the right balance by consistently collecting exactly the data we need to make informed decisions.”

Roy S. Herbst, MD, PhD

AACR cochair Roy S. Herbst, MD, PhD, from Yale Cancer Center, added, “Knowing about the smoking status and cessation attempts of all patients, but specifically those enrolled in a clinical trial, can be very important to understanding the results of that trial. Cancer patients and survivors who continue to smoke have worse health outcomes, higher risk of recurrence, and poorer response to and increased toxicity from treatment. Therefore, it is critically important to assess and address smoking during oncology therapeutic clinical trials.”

Please register to join us at the workshop. Let us know your questions about tobacco use assessment in oncology therapeutic trials by commenting here or by tweeting using the hashtag #OCETobaccoUse.